EMA advises limited use of Celltrion COVID-19 drug, says benefits still unclear (updated)

Celltrion

26/03/2021 12:10

(Adds details from statement, background)
    March 26 (Reuters) - Europe's drug regulator said on Friday
South Korean drugmaker Celltrion's  068270.KS  COVID-19
treatment can be considered for patients at high risk of severe
illness, but added that the monoclonal antibody's benefits were
not entirely clear so far.
    The treatment, regdanvimab, may lower hospitalisation rates,
the European Medicines Agency (EMA) said, adding that its advice
was based on the conclusion of an initial review.
    The EMA's human medicines committee also concluded that
regdanvimab can be used to treat confirmed COVID-19 in adult
patients who do not need oxygen support.
    "Results from the first part of the study indicate that
regdanvimab may lower the rate of hospitalisation. However, the
results were not robust enough to reach a firm conclusion on the
medicine's benefits at this point in time," the EMA said https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19.
     
    The EMA review was undertaken to provide an opinion to
individual European nations making assessments on the possible
use of regdanvimab before a wider EU marketing authorisation is
decided upon.
     EMA's "rolling review" of the drug, aimed to speed up the
process of approval by allowing researchers to submit findings
in real time, is still ongoing.  urn:newsml:reuters.com:*:nL4N2KU4K7
    Celltrion's drug, and similar ones from Lilly  LLY.N  and
Regeneron  REGN.O  being reviewed by the EMA, are synthetically
produced copies of natural, infection-fighting proteins made by
the human body to build immunity. 

 (Reporting by Pushkala Aripaka in Bengaluru; Editing by
Ramakrishnan M.)
 ((Pushkala.A@thomsonreuters.com; Twitter: @pullthekart; Mobile:
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